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NCT01410227 · ClinicalTrials.gov registry record · Phase 3
Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD)
A Phase 3 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 49
- Enrollment target
NCT01410227 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 49 participants.
The verdict
NCT01410227, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 49 participants
- Enrollment target
Study Summary
The purpose of this Phase 3 study is to assess the pharmacokinetics of rVWF:rFVIII and rVWF, and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding events in subjects with severe hereditary von Willebrand disease (VWD).
Interventions
- DRUG Placebo
- BIOLOGICAL Recombinant von Willebrand factor (rVWF)
- BIOLOGICAL Recombinant factor VIIII (rFVIII)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2011-11-01 |
| Est. Completion | 2014-02-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01410227
The ClinicalTrials.gov registry entry for NCT01410227 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01410227 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01410227 about?
NCT01410227 is a clinical study titled "Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD)". The purpose of this Phase 3 study is to assess the pharmacokinetics of rVWF:rFVIII and rVWF, and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding events in subjects with severe hereditary von Willebrand disease (VWD).
What is the current status of trial NCT01410227?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 49 participants. The study started on 2011-11-01. Estimated completion is 2014-02-01.
What interventions are being tested in trial NCT01410227?
The interventions under investigation include: Placebo (DRUG), Recombinant von Willebrand factor (rVWF) (BIOLOGICAL), Recombinant factor VIIII (rFVIII) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01410227?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
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